Impact of non‐binding FDA guidances on primary endpoint selection in Alzheimer's disease trials
Abstract Introduction The U.S. Food and Drug Administration (FDA)'s guidances help describe the agency's current thinking on regulatory issues and serve as a means of informal policymaking that is non‐binding. This study examines the impact of two guidance documents for Alzheimer's di...
Saved in:
| Main Authors: | Jeffrey C. Yu, Jakub P. Hlávka, Elizabeth Joe, Frances J. Richmond, Darius N. Lakdawalla |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Wiley
2022-01-01
|
| Series: | Alzheimer’s & Dementia: Translational Research & Clinical Interventions |
| Subjects: | |
| Online Access: | https://doi.org/10.1002/trc2.12280 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
Similar Items
-
Endpoints: types, selection, interpretation of the results obtained on the example of cardiology studies
by: A. R. Navasardyan, et al.
Published: (2022-06-01) -
Surrogate endpoints in cost-effectiveness analysis for use in medical technology assessment
by: T. I. Busheva, et al.
Published: (2025-07-01) -
Characterizing circulating biomarkers for childhood dementia disorders: A scoping review of clinical trials
by: Arlene D'Silva, et al.
Published: (2025-03-01) -
Sarcopenia in Ageing and Chronic Illness: Trial Endpoints and Regulatory Issues
by: Stephan vonHaehling, et al.
Published: (2025-06-01) -
Measuring time saved in Alzheimer's disease: What is a meaningful slowing of progression?
by: Krista Lanctot, et al.
Published: (2025-04-01)